Overview: NIAAA Medications Development Program

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Overview NIAAA Medications Development Program

• Raye Z. Litten, Ph.D.
• Mark Egli, Ph.D.
• Co-Leaders
• Medications Development Team
• National Institute on Alcohol Abuse
• and Alcoholism
• May 26, 2005

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Medications Development is a High Priority at
NIAAA

• One of ten primary research outcome goals of NIH
• One of the more highly developed research
  programs at NIAAA

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NIAAA-Supported Clinical Pharmacological Studies
to Treat Alcohol Use Disorders

• 1 Phase 3 clinical studies
• 33 Phase 2 clinical trials
• 17 Phase 1 clinical trial

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NIAAA-Supported Clinical Studies to Reduce or
Prevent Drinking
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Promising Targets for Novel Agents

• CRF1 antagonists
• cannabinoid CB1 antagonists
• adenosine A2 antagonists
• NPY2 agonists
• glutamate mGuR5 antagonists
• GABAA alpha 1 and 5

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NIAAA-Supported Clinical Pharmacotherapy Trials
for Comorbid Alcoholics
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NIAAA-Supported Clinical Pharmacotherapy Trials
for Comorbid Alcoholics
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NIAAA-Supported Clinical Pharmacotherapy Trials
for Comorbid Alcoholics
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NIAAA-Supported Clinical Pharmacotherapy Trials
for Adolescents
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NIAAA-Supported Clinical Pharmacotherapy Trials
for Adolescents
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NIAAA-Supported Clinical Pharmacotherapy Trials
for Alcoholic Liver Disease
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Creation of a Medications Development Team
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Medications Development Team is
Multi-Disciplinary

• Expertise in
• Genomics, proteomics, and metabolomics
• Neuroscience
• Addiction
• Animal models
• Clinical pharmacology
• Clinical trials
• Health services
• Psychiatry
• Human development
• Alcohol liver disease, FAS, AIDS
• Technology transfer, patents, and intellectual
  properties

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Teams Goal
To facilitate and accelerate the discovery,
development, and delivery of medications to treat
high-risk drinking, alcohol abuse and dependence,
and alcohol-related medical disorders
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Aims of Medications Development Team

• Stimulate innovative research and development in
  support of medications development
• Establish internal mechanisms and decision-making
  protocols for evaluating and advancing lead
  compounds

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Aims of Medications Development Team

• Develop collaborative networks among government,
  academia, and private industry and organizations
• Develop evidence-based clinical trials standards
  with the FDA

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The Team developed a medications development plan

• The plan will
• Accelerate drug development from lab bench to
  patient to practitioner
• Advance interdisciplinary research
• Stimulate public private partnerships
• Themes of the NIH Roadmap

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Extramural Advisory Board (EAB) Review

• EAB reviewed the plan and identified the most
  important priorities for advancing the field of
  medications development
• Fulton Crews will present EABs recommendations